Interference No. 103,203
set forth in Figure 1 [of the Edgington patent], in order to establish priority the junior parties
must demonstrate an actual reduction to practice of a nucleotide sequence encoding said
amino acid residues.12
To prove actual reduction to practice, the court recently held in Estee Lauder Inc. v.
L’Oreal, S.A., 129 F.3d 588, 592, 44 USPQ2d 1610, 1613 (Fed. Cir. 1997) that
. . . an inventor must establish that he “‘actually prepared the composition and knew
it would work.’” Hahn v. Wong, 892 F.2d 1028, 1032, 13 USPQ2d 1313, 1317
(Fed. Cir. 1989) (quoting Mikus v. Wachtel [II], 542 F.2d 1157, 1159, 191 USPQ
571, 573 (CCPA 1976)); see also Burroughs Wellcome Co. v. Barr Lab., Inc., 40
F.3d 1223, 1228, 32 USPQ2d 1915, 1919 (Fed. Cir. 1994) (reduction to practice
requires “the discovery that an invention actually works” (emphasis added)): see
also Standard Oil Co. (Indiana) v. Montedison, S.p.A., 494 F. Supp. 370, 206
USPQ 676 (D. Del. 1980), aff’d, 664 F.2d 356, 212 USPQ 327 (3d Cir. 1981)
(reduction to practice requires a showing of three elements: (i) production of a
composition of matter satisfying the limitations of the count, (ii) recognition of the
composition of matter, and (iii) recognition of a specific practical utility for the
composition).
In the case before us, we find that the evidence of record demonstrates that each of
the junior parties recognized (1) that the DNA which they were sequencing encoded human
tissue factor based on the amino acid sequence data generated from the purified protein,
and/or the ability of the expression product of the isolated clones to react with polyclonal
antibodies (Nemerson Brief, p. 10; Edgington Brief, Paper No. 347, p. 8, Facts 9-12; Lawn
Brief, pp. 7-10), and (2) the utility of the nucleotide sequence encoding mature human
12As to the recitation of “[a]n isolated DNA segment” in both the original Count 1 and the present
Count 2, we construe this phrase as meaning that the DNA segment of the count does not “read on” the
DNA as it occurs in its natural state in the human genome. That is, we construe the term “isolated” as
introducing a “hand of man” aspect to the count and, thus, the DNA segment described therein is not a
product of nature. Diamond v. Chakrabarty, 447 U.S. 303 (1980).
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